FDA Inspection
Pentax of America IncPentax of America Inc – FDA Inspection, Dec 18, 2012
Record Details
This FDA Inspection record concerns Pentax of America Inc, with an inspection on December 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pentax of America Inc
- Inspection Date
- December 18, 2012
- Product Type
- Devices
View Company Profile
ID · 1a16fef7-d8e1-47e5-a564-89f0a1bf2906
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 812553
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pentax of America Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 27, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 2, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pentax of America Inc
- FDA Inspection 1211451 - 2023-07-20
- FDA Inspection 1066901 - 2018-09-27
- FDA Inspection 921077 - 2015-04-02
- FDA Inspection 906155 - 2014-12-17
- FDA Inspection 718354 - 2011-03-17
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